Effekt of nerandomilast on clinical outcomes in patients with progressive pulmonary fibrosis (PPF): results from the final database lock of the FIBRONEER-ILD trial*

Introduction: FIBRONEER-ILD was a randomised placebo-controlled trial of nerandomilast 9 mg bid and 18 mg bid in patients with PPF. The primary endpoint (change in FVC [mL] over 52 weeks) was met for both doses. Patients continued trial drug beyond 52 weeks until the last patient completed the end-of-treatment visit. Aim: Assess the effects of nerandomilast on time-to-event endpoints up to final database lock in the FIBRONEER-ILD trial. Methods: Time to first acute exacerbation, hospitalisation for respiratory cause, or death (key secondary endpoint) and other time-to-event endpoints were assessed. Results: 1176 patients received trial drug; 43.5% were taking background nintedanib. Up to final database lock, mean (SD) exposure to trial medication was 15.1 (5.7) months and observation time was 17.0 (4.1) months. The risk of occurrence of these endpoints was lower with both doses of nerandomilast versus placebo: the key secondary endpoint, acute exacerbation or death, hospitalisation for respiratory cause or death, death, absolute decline in FVC% predicted>10% or death ([ Fig. 1 ]). The safety profile of nerandomilast was consistent with that observed over 52 weeks. Conclusions: In the FIBRONEER-ILD trial in patients with PPF, nerandomilast 9 mg bid and 18 mg bid reduced the risk of multiple clinical outcomes, including death, compared with placebo. *previously presented at the European Respiratory Society (ERS) congress 2025; The presenter is presenting on behalf of the authors Fig. 1 Publication History Article published online: 04 March 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany